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康方生物-B(09926.HK):依沃西(PD -1 / VEGF,AK112)近期獲國家藥監局授予三項突破性療法認定
格隆匯 11-14 08:19

格隆匯11月14日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的全球首創雙特異性抗體新藥依沃西( PD -1 / VEGF,AK112)於近期獲得國家藥監局藥品審評中心(CDE)授予三項突破性療法認定。該三項認定分別為:AK112聯合化療治療EGFR-TKI耐藥的EGFR突變的局部晚期或轉移性非鱗狀非小細胞肺癌(NSCLC),該研究已於近期完成III期臨牀試驗的受試者入組;AK112一線治療PD -L1表達陽性的局部晚期或轉移性NSCLC,該研究目前正在開展III期臨牀試驗;AK112聯合多西他賽治療既往PD-(L)1抑制劑和含鉑化療治療失敗的局部晚期或轉移性NSCLC,是國內目前唯一在PD-(L)1耐藥的肺癌治療領域獲得突破性療法認定的藥物品種。

公吿表示,突破性療法認定旨在加速在治療嚴重疾病領域,且早期臨牀研究已顯示出令人鼓舞的結果的新藥研發進程。該類藥物或在臨牀終點比現有療法有重大改善,或滿足重大未滿足的醫療需求。公司堅信AK112在多個NSCLC臨牀研究上都獲得該類認定必將有助於該產品加速研發和上市的進程。

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